Applied Therapeutics Reports Fourth Quarter and Year-End 2020 Financial Results
18 Marzo 2021 - 12:00PM
Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage
biopharmaceutical company developing a pipeline of novel drug
candidates against validated molecular targets in indications of
high unmet medical need, today reported financial results for the
fourth quarter and full year ended December 31, 2020.
“The fourth quarter was a productive period of
internal planning and execution,” said Shoshana Shendelman, PhD,
Founder, CEO and Chair of the Board of Applied Therapeutics. “We
are excited for what lies ahead in 2021, where our focus will be on
advancing our late stage assets toward commercialization while
initiating clinical development of our two new rare disease
programs.”
Recent Highlights
- Announced Restart of
Pediatric Galactosemia Study. In February
2021, the Company announced that the FDA lifted the clinical hold
on the AT-007 ACTION-Galactosemia Kids pediatric clinical study,
and the study resumed immediately. Applied Therapeutics
worked closely with FDA to modify the trial, with the shared goal
of ensuring that all patients have the opportunity to receive
clinical benefit, and remains on target to submit an NDA no later
than Q3 2021.
- Announced the Launch of a
Galactosemia Awareness and Education
Initiative. Galactosemia Together is the first
and only industry-led Galactosemia awareness and education
campaign. Developed in partnership with the
Galactosemia community, this initiative aims to address gaps in
education by providing updated, reliable and credible resources to
help connect, educate and support those families impacted by this
disease.
- Announced Magnetic
Resonance Spectroscopy (MRS) Data from ACTION-Galactosemia
Study. In December 2020, the Company shared
MRS data on reduction of galactitol levels in the brain of
Galactosemia patients treated with AT-007 in the
ACTION-Galactosemia adult study. Overall, plasma
reduction in galactitol correlated with brain reduction in
galactitol. At the two doses which demonstrated
statistically significant reduction in plasma galactitol, 20 and
40mg/kg, 3 out of 4 patients displayed substantial galactitol
reduction ranging from 61.94% to 69.80% reduction from
baseline.
- Closed Public Offering of
3,000,000 Shares of Common Stock at a Price to the Public of $23.00
Per Share. In February 2021, the Company completed an
underwritten public offering of 3,450,000 shares of common stock,
including the exercise in full of the underwriters’ option to
purchase 450,000 additional shares of common stock at a price
of $23.00 per share, resulting in aggregate net proceeds
of approximately $74.3 million.
Financial Results
- Cash and cash equivalents
and short-term investments totaled $96.8 million as of
December 31, 2020, compared with $38.9 million at December 31,
2019. This does not include approximately $74.3 million
in aggregate net proceeds the Company received from the
underwritten public offering of common stock in February 2021.
- Research and development
expenses for the year ended December 31, 2020 were $61.8
million, compared to $32.4 million for the year ended December 31,
2019. The increase of $29.4 million related to an increase in
clinical and pre-clinical expense of $11.3 million, primarily
related to the progression of the AT-007 ACTION-Galactosemia adult
extension and the AT-001 Phase 3 ARISE-HF clinical studies, as well
as the commencement and progression of the AT-007
ACTION-Galactosemia Kids pediatric registrational study; an
increase in drug manufacturing and formulation expenses of $15.4
million primarily related to the commencement of the 2020
manufacturing campaigns and the associated raw material deliveries
and AT-007 and AT-001 drug product batch releases; an increase in
personnel expenses of $0.6 million due to the increase in headcount
in support of our clinical program pipeline; a decrease in
stock-based compensation of $0.2 million due to the stock option
modification expense recognized during the year ended December 31,
2019 for the acceleration of certain options vesting following the
IPO; offset by an increase in expense recognized during the year
ended December 31, 2020 due to new stock option and restricted
stock grants; and an increase of regulatory and other expenses of
$2.3 million primarily related to University of Miami license fees
and increased clinical consulting fees recognized during the year
ended December 31, 2020.
- General and administrative
expenses were $32.7 million for the year ended December
31, 2020, compared to $13.2 million for the year ended December 31,
2019. The increase of $19.4 million was an increase in professional
and legal fees of $4.1 million due to increased operations and
costs associated with being a public company for a full year; an
increase of $5.7 million related to the establishment of a
commercial department; an increase in personnel expenses of $4.2
million and an increase in stock-based compensation of $2.0 million
due to an increase in headcount; an increase of insurance expenses
of $1.8 million related to increased D&O insurance costs; and
an increase in other expenses of $1.6 million, primarily relating
to increased costs of rent and other office expenses.
- Net loss for the
year ended December 31, 2020 was $94.0 million, or $4.28 per basic
and diluted common share, compared to a net loss of $45.5 million,
or $3.55 per basic and diluted common share, for the year ended
December 31, 2019.
About Applied
TherapeuticsApplied Therapeutics is a clinical-stage
biopharmaceutical company developing a pipeline of novel drug
candidates against validated molecular targets in indications of
high unmet medical need. The Company’s lead drug candidate, AT-007,
is a novel central nervous system penetrant aldose reductase
inhibitor (ARI) for the treatment of Galactosemia, a rare pediatric
metabolic disease. The Company initiated a pivotal Phase 1/2
clinical trial in June 2019, read out positive top-line biomarker
data in adult Galactosemia patients in January 2020 and announced
full data from the trial in April 2020. A pediatric Galactosemia
study commenced in June 2020. The Company is also developing
AT-001, a novel potent ARI that is being developed for the
treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of
the heart. The Company initiated a Phase 3 registrational study in
DbCM in September 2019. The preclinical pipeline also includes
AT-003, an ARI designed to cross through the back of the eye when
dosed orally, for the treatment of diabetic retinopathy, as well as
novel dual PI3k inhibitors in preclinical development for orphan
oncology indications.
Forward-Looking StatementsThis
press release contains “forward-looking statements” that involve
substantial risks and uncertainties for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of
1995. Any statements, other than statements of
historical fact, included in this press release regarding strategy,
future operations, prospects, plans and objectives of management,
including words such as “may,” “will,” “expect,” “anticipate,”
“plan,” “intend,” and similar expressions (as well as other words
or expressions referencing future events, conditions or
circumstances) are forward-looking statements. These
include, without limitation, statements regarding (i) the timing of
our NDA submission for potential approval of AT-007, which will
include data from the ACTION-Galactosemia Kids trial and the 90-day
safety data in adults with Galactosemia, (ii) the timing of our
rare disease franchise expansion programs in SORD Deficiency and
PMM2-CDG, (iii) the timing and effectiveness of our Galactosemia
awareness and education campaign, (iv) the timing of the initiation
and completion of our clinical trials, (v) the likelihood that data
from our clinical trials will support future development of our
product candidates and (vi) the likelihood of obtaining regulatory
approval of our product candidates. Forward-looking
statements in this release involve substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by the forward-looking statements,
and we, therefore cannot assure you that our plans, intentions,
expectations or strategies will be attained or achieved.
Such risks and uncertainties include, without
limitation, (i) our plans to develop and commercialize our product
candidates, (ii) the initiation, timing, progress and results of
our current and future preclinical studies and clinical trials and
our research and development programs, (iii) our ability to take
advantage of expedited regulatory pathways for any of our product
candidates, (iv) our estimates regarding expenses, future revenue,
capital requirements and needs for additional financing, (v) our
ability to successfully acquire or license additional product
candidates on reasonable terms, (vi) our ability to maintain and
establish collaborations or obtain additional funding, (vii) our
ability to obtain regulatory approval of our current and future
product candidates, (viii) our expectations regarding the potential
market size and the rate and degree of market acceptance of such
product candidates, (ix) our ability to fund our working capital
requirements and expectations regarding the sufficiency of our
capital resources, (x) the implementation of our business model and
strategic plans for our business and product candidates, (xi) our
intellectual property position and the duration of our patent
rights, (xii) developments or disputes concerning our intellectual
property or other proprietary rights, (xiii) our expectations
regarding government and third-party payor coverage and
reimbursement, (xiv) our ability to compete in the markets we
serve, (xv) the impact of government laws and regulations and
liabilities thereunder, (xvi) developments relating to our
competitors and our industry, (xvii) the impact of the COVID-19
pandemic on the timing and progress of our ongoing clinical trials
and our business in general and (xviii) other factors that may
impact our financial results. In light of the significant
uncertainties in these forward-looking statements, you should not
rely upon forward-looking statements as predictions of future
events. Although we believe that we have a reasonable basis for
each forward-looking statement contained in this press release, we
cannot guarantee that the future results, levels of activity,
performance or events and circumstances reflected in the
forward-looking statements will be achieved or occur at all.
Factors that may cause actual results to differ from those
expressed or implied in the forward-looking statements in this
press release are discussed in our filings with the U.S. Securities
and Exchange Commission, including the “Risk Factors” contained
therein. Except as otherwise required by law, we disclaim any
intention or obligation to update or revise any forward-looking
statements, which speak only as of the date they were made, whether
as a result of new information, future events or circumstances or
otherwise.
Contacts
Investors:Maeve Conneighton(212) 600-1902
orappliedtherapeutics@argotpartners.com
Media:media@appliedtherapeutics.com
Applied Therapeutics,
Inc.Statements of Operations(in
thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
OPERATING EXPENSES: |
|
|
|
|
|
|
Research and development |
|
$ |
61,788 |
|
|
$ |
32,350 |
|
General and administrative |
|
|
32,678 |
|
|
|
13,232 |
|
Total operating expenses |
|
|
94,466 |
|
|
|
45,582 |
|
LOSS FROM OPERATIONS |
|
|
(94,466 |
) |
|
|
(45,582 |
) |
OTHER INCOME (EXPENSE),
NET: |
|
|
|
|
|
|
Interest income (expense), net |
|
|
559 |
|
|
|
93 |
|
Other income (expense) |
|
|
(54 |
) |
|
|
(24 |
) |
Total other income (expense), net |
|
|
505 |
|
|
|
69 |
|
Net loss |
|
$ |
(93,961 |
) |
|
$ |
(45,513 |
) |
Net loss attributable to
common stockholders—basic and diluted |
|
$ |
(93,961 |
) |
|
$ |
(45,513 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
|
$ |
(4.28 |
) |
|
$ |
(3.55 |
) |
Weighted-average common stock
outstanding—basic and diluted |
|
|
21,966,326 |
|
|
|
12,831,221 |
|
|
|
Applied Therapeutics,
Inc. Balance Sheets (in
thousands, except share and per share data)
|
|
|
|
|
|
|
As of |
|
As of |
|
|
December 31, |
|
December 31, |
|
|
2020 |
|
2019 |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
57,466 |
|
|
$ |
18,850 |
|
Investments |
|
|
39,363 |
|
|
|
20,004 |
|
Prepaid expenses and other current assets |
|
|
5,764 |
|
|
|
7,301 |
|
Total current assets |
|
|
102,593 |
|
|
|
46,155 |
|
Operating lease right-of-use asset |
|
|
1,712 |
|
|
|
2,035 |
|
Security deposits and leasehold improvements |
|
|
201 |
|
|
|
199 |
|
TOTAL ASSETS |
|
$ |
104,506 |
|
|
$ |
48,389 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
Current portion of operating lease liabilities |
|
$ |
406 |
|
|
$ |
356 |
|
Accounts payable |
|
|
640 |
|
|
|
8,793 |
|
Accrued expenses and other current liabilities |
|
|
20,189 |
|
|
|
4,950 |
|
Total current liabilities |
|
|
21,235 |
|
|
|
14,099 |
|
NONCURRENT LIABILITIES: |
|
|
|
|
|
|
Noncurrent portion of operating lease liabilities |
|
|
1,332 |
|
|
|
1,683 |
|
Total noncurrent liabilities |
|
|
1,332 |
|
|
|
1,683 |
|
Total liabilities |
|
|
22,567 |
|
|
|
15,782 |
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
Common stock, $0.0001 par value; 100,000,000 shares authorized as
of December 31, 2020 and December 31, 2019;
22,493,661 shares and 18,531,560 shares issued and outstanding as
of December 31, 2020 and December 31, 2019,
respectively |
|
|
2 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
242,780 |
|
|
|
99,378 |
|
Accumulated other comprehensive loss |
|
|
(112 |
) |
|
|
(2 |
) |
Accumulated deficit |
|
|
(160,731 |
) |
|
|
(66,770 |
) |
Total stockholders' equity |
|
|
81,939 |
|
|
|
32,607 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
104,506 |
|
|
$ |
48,389 |
|
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